Neonatal closed system for involuntary aspiration and ventilation and method

ABSTRACT

Apparatus for respiratory therapy, which is particularly useful in a neonatal context, and related methods, the apparatus comprising an adaptor for connection to the exposed fitting of an indwelling endotracheal tube of any one of several types to an aspirating apparatus which may include ventilating capacity. The adaptor includes an appendage by which a lavage solution can be selectively introduced into the lungs of a patient through the indwelling endotracheal tube to loosen secretions without necessarily interrupting the ventilation cycle or requiring that the ventilating circuit be broken. The apparatus also comprises a fitting at one end of an aspirating/ventilating apparatus which has low dead space, alleviating the incidence of inadvertent disconnection and trauma induced by unintended displacement of the end fitting and accommodating not only aspiration and ventilation but also monitoring of certain vital indicators to allow prompt medical response to contraindications. The apparatus further comprises a manual stationary insertion guide for introduction of the suction catheter tube into the respiratory system of the patient and control stop structure which accommodates insertion into the respiratory system of the patient of only a predetermined length of the suction catheter tube. The apparatus also comprises structure by which the flow of secretions through the suction catheter tube can be visually monitored.

FIELD OF THE INVENTION

The present invention relates generally to involuntary ventilation ofthe respiratory system of a medical patient and involuntary aspirationof secretions from the lungs of the patient and more particularly to anovel neonatal suctioning device, and related method, the device beingused in conjunction with an indwelling endotracheal tube typicallyplaced, for example, in the throat of a newborn infant by whichaccumulated secretions are selectively evacuated from the lungs of theinfant without injury to the infant.

PRIOR ART

Respiratory distress frequently occurs in infants and small childrenexperiencing respiratory problems. This is commonplace in prematureinfants. When an infant or small child is unable to breathe adequatelyon its own, intubation and involuntary ventilation is provided via anendotracheal tube. This requires periodic, involuntary removal, via asmall suction catheter tube, of secretions which accumulate in thelungs, without injury to or penetration of the lungs with the suctioncatheter tube. Precise control in placement of the suction catheter tubeis also of great concern because of the risk of trauma, and injury,during placement. Bulky paraphernalia can incumber movement of the childand be the source of injury to the child, for example, if caught in thebed clothing of the child. Also, adaption for otherwise incompatibleendotracheal and ventilating and aspirating equipment from differentsources has not heretofore been available. Furthermore, the option ofintroduction of a lavage solution into the lungs to loosen secretionswithout breaking the ventilation circuit has not been satisfactorilyaddressed heretofore.

Monitoring of certain vital medical information and the efficacy of thesecretion removal process are important, so that any contraindication onthe part of the child can be medically addressed without delay.

None of the neonatal ventilation/aspirating devices proposed by theprior art address the problems associated with proper medical care forinfants and small children.

The most relevant, known aspirating/ventilating prior art patents areU.S. Pat. Nos. 3,991,762 and 4,569,344. These do not per se address theaforementioned neonatal needs. In each case, an essentially linearcatheter tube is provided for insertion into and removal of secretionsfrom the lungs of a medical patient.

The literature, with one exception, does not address neonatal needs, butdiscloses straight-tip, curved-tip and angled-tip suction catheters, useof guide marks, in the form of dots, together with radiopaque liquid forcatheter tip placement, control of the length of the catheter to preventkinking and avoidance of catheter rotation during placement.

The literature also discusses single-use, non-ventilating devices, oneexample of which is Davol's aspirating catheter assembly, whichcomprises a sterile bag, a catheter tube within the bag and a ventfitting at the proximal end of the assembly, which is operated toaspirate by placing a thumb or finger over an atmospheric vent port.

The one neonatal aspirating/ventilating device disclosed in theliterature includes expensive electronic gear, comprises bulky, highdead space components and does not provide facile and accurate controlfor periodic suction catheter tube placement in the lungs of a child.

BRIEF SUMMARY AND OBJECTS OF THE PRESENT INVENTION

In brief summary, the present invention is intended to overcome orsubstantially alleviate the aforementioned limitations of the prior artand comprises a novel apparatus for respiratory therapy, which isparticularly useful in a neonatal context and related methods.

Features of the present invention which are noteworthy include: (a)provision for facile, injury-free and accurate placement of anaspirating suction catheter tube in the desired location within therespiratory system of the patient; (b) compatible adaption interposedbetween the exposed fitting of an indwelling endotracheal tube of anyone of several types and an aspirating apparatus or anaspirating/ventilating apparatus; (c) provision of an adaptor by which alavage solution can be selectively introduced into the lungs of apatient through an existing indwelling endotracheal tube to loosensecretions without necessarily interrupting the ventilation cycle orrequiring that the ventilating circuit be broken; (d) a novel fitting atone end of an aspirating/ventilating apparatus which has low dead space,alleviating the incidences of inadvertent disconnection and traumainduced by unintended displacement of the fitting and accommodating notonly aspiration and ventilation but also monitoring of certain vitalindicators to allow prompt medical response to contraindications; (e) aninsertion guide for the suction catheter tube; (f) control structurewhich accommodates insertion into the respiratory system of the patientof only a predetermined length of the suction catheter tube; and (g)structure by which the flow of secretions through a suction cathetertube can be visually monitored.

With the foregoing in mind, it is a primary object of the presentinvention to provide a novel apparatus for respiratory therapy, which isparticularly useful in a neonatal context, and a related method.

It is a further important object of the present invention to provideapparatus for respiratory therapy which accommodates facile, accurateand injury-free placement of an aspirating suction catheter tube in adesired location within the respiratory system of a patient.

A further dominant object of the present invention is the provision of anovel adaptor to be interposed between an exposed fitting and anindwelling endotracheal tube of any one of several types of anaspirating apparatus or an aspirating/ventilating apparatus toaccommodate aspiratory therapy or aspiratory/respiratory therapy.

A further paramount object of the present invention is the provision ofa novel adaptor by which a lavage solution can be selectively introducedinto the lungs of a patient through an existing indwelling endotrachealtube to loosen secretions within the lungs without necessarilyinterrupting the ventilation cycle or requiring that the ventilatingcircuit be broken.

A further object of significance is the provision of a novel fitting atone end of an aspirating/ventilating apparatus which has low dead space,alleviates the incidence of inadvertent disconnection and trauma inducedby unintended displacement of the fitting and accommodates not onlyaspiration and ventilation but also the monitoring of certain vitalpatient indicators to allow prompt medical response tocontraindications.

An additional dominant object of the present invention is the provisionof an insertion guide for a suction catheter tube of an aspirating oraspirating/ventilating apparatus;

A further object of significance is the provision of control structurein association with a suction catheter tube which accommodates insertioninto the respiratory system of the patient of only a predeterminedlength of the catheter tube to thereby prevent lung injury.

Another object of importance is the provision of structure by which theflow of secretions being removed from a selected lung of a patientthrough a suction catheter tube can be accurately visually monitored.

These and other objects and features of the present invention will beapparent from the detailed description taken with reference to theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a fragmentary perspective of one presently preferredembodiment of the present invention;

FIG. 2 is an enlarged perspective representation of the insertion guidefor the suction catheter tube of the apparatus of FIG. 1 with thecollapsible envelope removed;

FIG. 3 is a cross-section taken along lines 3--3 of FIG. 2 showing theexternal collapsible envelope and the suction catheter tube held betweentwo fingers of the user, showing the preferred mode of insertion of thesuction catheter tube into the respiratory system of a patient using theinsertion guide;

FIG. 4 is a cross-section taken along lines 4--4 of FIG. 2;

FIG. 5 is a cross-section taken along lines 5--5 of FIG. 2;

FIG. 6 is a side elevation view of a suction catheter tube insertioncontrol device compressively assembled at a predetermined location alongthe exterior of the suction catheter tube;

FIG. 7 is an exploded cross-sectional view of the components of thesuction catheter tube insertion control device of FIG. 6;

FIG. 8 is a side elevation view of the suction catheter tube controldevice of FIG. 6 in its locked condition illustrated as having reachedits stop site where the insertion control device engages the trailingend of the suction catheter tube insertion guide;

FIG. 9 is a cross-section taken along lines 9--9 of FIG. 1;

FIG. 10 is a cross-section taken along lines 10--10 of FIG. 1;

FIG. 11 is an exploded fragmentary perspective of a further embodimentof the present invention in the form of an adaptor interposed between anexposed fitting of an indwelling endotracheal tube and an aspirating oraspirating/ventilating apparatus to accommodate introduction of a lavagesolution into the lungs of a patient to loosen accumulated secretions;

FIG. 12 is an enlarged perspective of the adaptor of FIG. 11, theorientation of which is reversed in comparison with FIG. 11;

FIG. 13 is a cross-section taken along lines 13--13 of FIG. 12;

FIG. 14 is a cross-section taken along lines 14--14 of FIG. 12;

FIG. 15 illustrates in fragmentary perspective a further embodiment ofthe present invention in the form of a secretion removal observationchamber interposed between the trailing end of a suction catheter tubeand a control valve;

FIG. 16 is an exploded perspective representation of the embodiment ofthe present invention of FIG. 15;

FIG. 17 is a cross-section taken along the lines 17--17 of FIG. 16;

FIG. 18 is an end view taken along lines 18--18 of FIG. 16; and

FIG. 19 is and end view taken along lines 19--19 of FIG. 16.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

Preferred embodiments of the present invention are illustrated in thedrawings to which reference is now made and wherein like numerals areused to designate like parts throughout.

One presently preferred embodiment, comprising a ventilating/aspiratingmechanism, is illustrated isometrically in FIG. 1 and is generallydesignated 30. The ventilating/aspirating mechanism 30 broadly comprisesa ventilating/aspirating connector fitting 32, with which the apparatus30 is connected to an exposed end of an indwelling endotracheal tube inpress-fit, air-tight relationship. With the exception of fitting 32,apparatus is substantially similar to the apparatus disclosed in U.S.Pat. No. 4,569,344. The mechanism 30 thus also comprises a centrallydisposed, axially directed suction catheter tube, generally designated34, which is illustrated as being contained within a collapsibleenvelope, generally designated 36. The envelope 36 may be formed ofsynthetic resinous film in sleeve form, which is force-fit connected atcollar 38 associated with the trailing end of the fitting 32 and alsoforce-fit connected to a suction control valve 40 via collar 42 near thetrailing end of the apparatus.

The catheter tube 34 is adapted to be displaced snugly through thefitting 32 and is rigidly anchored to the control valve 40 at site 44.Apparatus 30 further comprises the suction catheter tube insertionguide, generally designated 44. Insertion guide 44 is stationarilyjoined to the trailing end of the fitting 32.

The suction control valve 40 comprises a stepped hollow projection 46 bywhich the valve 40 is connected in fluid communication with a source ofnegative pressure, such as a conventional hospital suction system.

Specific reference is now made to FIGS. 1, 9 and 10 for the purpose ofdescribing in greater detail the aspirating/ventilating fitting 32.Preferably, fitting 32 is of one piece molded construction, formed usingconventional injection molding techniques. Fitting 32 may be transparentto permit visual observation of the interior thereof. The fitting 32comprises a female barrel 50, which comprises a circular wall 52illustrated as being of uniform thickness throughout, the barrel 50comprising exterior and interior cylindrical wall surfaces 54 and 56,respectively. The leading edge 58 is blunt.

Thus, at the fore end of the fitting 32, the barrel 50 is ofsubstantially uniform inside diameter, sized and shaped so that theinterior of the barrel 50 will snugly match the female exposed connectorof an indwelling endotracheal tube for press-fit connection in asubstantially air-tight fashion. Such connection is intended not tointerfere with the flow of ventilating air, or certain monitoringfunctions as hereinafter more fully explained.

The overall interior length of the female bore 56 is illustrated asbeing approximately one-half of the overall axial length of theconnector fitting 32. The barrel or wall 52 is interrupted by threeco-planer transversely-directed integral port structures 60, 62 and 64,each of which has a hollow cylindrical interior of uniform diameterthroughout in open communication with the axially-directed fore bore 56of the fitting 32, the open cylindrical interior thereof beingidentified respectively as 66, 68 and 70. The port structures each endin a blunt transverse end edge 61, 63 and 65 respectively. See FIG. 10.

The uniform cylindrical nature and the size of the hollow interior ofeach port structure 60, 62 and 64 accommodates press-fit reception ofconventional male coupling members, the interior of the port structures60 and 62 being illustrated as being connected to the input and outputof a conventional ventilator 72 (FIG. 1) by hollow conventional tubing,diagrammatically illustrated at 74 and 76, respectively. The hollowinterior 70 of the port structure 64 is illustrated, in FIG. 1, as beingconnected to a conventional temperature monitor 78, for continuousmonitoring of the respiratory temperature of the associated patient toaccommodate immediate medical response to any temperaturecontraindication.

The port structures 60, 62 and 64 are closely juxtaposed one to the nextand are downwardly directed toward the chest of the patient when theapparatus is in use. This is of particular significance for neonatal useas it eliminates or greatly alleviates inadvertent separation of thefitting 32 from the exposed fitting of an indwelling endotracheal tubeor the connections to the ventilator or monitors. It also eliminatestrauma induced by inadvertent displacement of the fitting 32 during themovement of the patient, as, for example, when bed clothing wouldotherwise be caught on projections of prior art fittings used to connectventilating/aspirating apparatus to an indwelling endotracheal tube,etc.

The fitting 32, toward the trailing end thereof, has an additionaldownwardly directed port structure 80, having a hollow, cylindricalinterior 82 into which a male fitting 84 (FIG. 1) is illustrated asbeing force-fit and to which the trailing end a hollow tube 86,diagrammatically illustrated in FIG. 1, can be used to conventionallyconnect the port structure 80 to a conventional pressure monitor 88which normally is part of the ventilator 72. The port structure 80terminates in a blunt edge 81. With reference to FIG. 9, it is to beappreciated that the hollow cylindrical interior 82 of the portstructure 80 connects on a 90 degree angular basis with a rectangularpassageway 90 and thence with the hollow bore interior 56 of the barrel50. Thus, the pressure of the infant or other patient can becontinuously monitored to thereby accommodate immediate response to anypressure contraindication.

It is to be appreciated that in the event that the apparatus 30, withthe fitting 32 in place, is used with certain types of equipmentexisting in various medical facilities not having pressure monitoring ortemperature monitoring capacity, the hollow interior of the portstructure 64 and 80 can be selectively plugged with a removal plug.

The fitting 32, as best illustrated in FIG. 9, comprises an arcuate orcurvilinear shoulder 92 adjacent the top region of the wall surface 54,at the trailing end thereof which merges with an arcuate exposed surface94 of reduced diameter. Surface 94 merges with an upwardly projectinghollow circular boss 96, the interior surface 98 of which has a uniformdiameter. The uniform bore 98 extends transversely from the exterior toa relatively small interior axial bore 100 disposed near the aft end ofthe fitting 32. The axial bore 100 is sized and shaped so as to snuglyaccommodate linear passage of the suction catheter tube 34 therethroughin such a way as to create a substantially sealed relationship at site101 between the exterior of the catheter 34 and the bore 100. Thisprevents inflation or deflation of the interior of the envelope 36.

The bore 100 comprises part of a body of material 102, which has aforward tapered leading surface 104 and is joined to the trailing end ofthe barrel 50, of wall 93. The body of material 102 merges with arearwardly directed hollow annulus 106 which comprises a circular wallof uniform thickness defining an interior cylindrical surface 108 and anexterior cylindrical surface 110. The interior surface 108 merges withthe much smaller axial bore 100 at tapered counterbore 112. The taperedsurface of counterbore 112 deflects the leading end 120 (FIG. 1) of thesuction catheter tube 34 when contact therebetween is made duringcatheter tube advancement. This catheter tube tip 120 deflection bringsthe tip 120 into alignment with the bore 100.

The exterior surface 110 of the annulus 106 accommodates connectionbetween the fitting 32 and the insertion guide 44, in a mannerhereinafter more fully described.

A catheter tube wash structure 122 is connected to the fitting 32 withinthe upwardly directed bore 98. More specifically, the structure 122comprises a flexible hollow tube 124, the outside diameter of which issubstantially the same as the diameter of the bore 98. The one end ofthe tube 124 is caused to be advanced into the bore 98 after the end 126is coated with a suitable adhesive or bonding agent. Thus, the end 126of the tube 124 becomes integrally joined to the surface forming thebore 98 of the fitting 32.

The tube 124 integrally merges with a larger female fitting 128, whichis normally closed by a cap 130 press-fit upon the female fitting 128.The cap 130 is tethered at 132 to the fitting 128 so that the cap 130does not become lost when it is removed and wash solution is caused tobe passed under pressure through the fitting 128 and the tube 120 towash the exterior of the catheter tube 34 as it is withdrawn from therespiratory system of the patient and to wash the interior of thecatheter tube when fully withdrawn. This procedure is described ingreater detail in U.S. Pat. No. 4,569,344. This procedure removes allsecretions which would otherwise remain upon the exterior and interiorsurfaces of the catheter tube 34 after withdrawal.

The flexible nature of the tubing 124 allows the structure 122 to flexreadily when contacted by the patient, the clothing of the patient orthe like so that snagging does not occur and the apparatus 30 is notinadvertently disconnected in any way and trauma which would otherwisebe induced by displacement of the apparatus 30 is avoided.

Specific reference is now made to FIGS. 1 through 5 for purposes ofdescribing the insertion guide 44 in detail. As can be seen from FIG. 3,the insertion guide 44 is disposed, in the assembled condition, internalof the plastic envelope 36 in such a way that the suction catheter tube34 is loosely centrally disposed therethrough.

The leading end of the insertion guide 44 comprises a hollow steppedsleeve, generally designated 140. See FIG. 2. Sleeve 140 comprises anenlarged collar 142 at the leading tip thereof. Collar 142 iscylindrical and of uniform thickness. Collar 142 comprises a blunt end144 and a uniform interior diameter at surface 146. The diameter ofsurface 146 (FIG. 2) is substantially the same as the diameter of theexterior surface 110 of the fitting 32. Consequently, by interposing asuitable adhesive or bonding agent between the surface 110 and thesurface 146 and superimposing 110 over 146, the insertion guide 44 isintegrally and stationarily joined to the fitting 32. As such, guide 44extends rearwardly in cantilevered relationship. See FIG. 1.

The collar 142 is internally stepped at shoulder 148 and externallystepped at shoulder 150 to form reduced diameter inside and outsidecylindrical segment comprising surfaces 152 and 154. The internal boreformed by surface 152 is further reduced at internal shoulder 153whereby cylindrical surface 155 results. Reduced bore 155 is followed bycounterbore 157. Counterbore 157 terminates in a constriction at orifice159, the diameter of which is slightly larger than the outside diameterof the tube 34.

The exterior cylindrical surface 154 is interrupted just forward of thetrailing shoulder 156 by an annular radially extending rib 158.

The insertion guide 44 is preferably formed of a suitable syntheticresinous material fabricated in one piece using conventional injectionmolding techniques. The insertion guide 44 further comprises top andbottom longitudinally-directed beam members 160 and 162, each of whichis illustrated as being rectangular in cross-section and identical oneto another. The leading end 164 and 166 of each is integrally joined tothe trailing end of the sleeve 140 adjacent counterbore 157 and shoulder156. Each beam member 160 and 162 extends rearwardly for a distance ofseveral centimeters. For example, the inserter guide 44 may be fivecentimeters in length. Of course, other lengths could be used, dependingupon the overall size of the ventilating/aspirating apparatus amongother things.

The beams 160 and 162 are thus parallel to, but respectively oppositelyoffset from the axis of the sleeve 140 and the fitting 32 through whichthe suction catheter tube 34 is advanced into a desired lung of thepatient where accumulated lung secretions are to be removed. Theparallel beam members 160 and 162 are joined one to another by anintegral ring 168 disposed at the trailing end 170 thereof. The ring 168has a blunt leading edge 172 and a blunt trailing edge 174. The exteriordiameter of the ring 168 is illustrated as being less than the diameterof the sleeve portion 154 while the internal diameter at surface 176 ofthe ring 174 is illustrated as being substantially the same as thedistance between the beam members 160 and 162.

With the annular collar 38 force-fit securing the leading end of thecollapsible plastic envelope 36 to the surface 154 of the sleeve 140 (byplacing the annular projection 150 between two inwardly directedprojections on the interior surface of the collar 38 as explained inU.S. Pat. No. 4,569,344, and the apparatus 30 otherwise assembled in itsready-to-use condition, the user, as illustrated in FIG. 3, firmly gripsthe plastic envelope 36 at the opposed exterior side surfaces thereoftightly against the exterior surface of the suction catheter tube 32.Preferably the outside diameter of the catheter tube 32 is wider thanthe width of the beam at members 160 and 162.

Thereafter, the user advances the suction catheter tube 34 and theexterior envelope 36 axially slidably along the guide 44, through thefitting 32 and the indwelling endotracheal tube into a desired locationwithin the respiratory system of the patient. It should be clear thatwhile the external envelope 36 and the catheter tube 34 are held tightlyand advanced by the fingers of the user, the engagement of the bars 160and 162 between the fingers is slidable and accommodates a linearadvance of the envelope 36 and the tube 32 parallel to the stationarybars 160 and 162.

The advancing step is repeated as many times as necessary to insert adesired length of catheter tube into a selected lung of the patient andposition the same so that accumulated secretions within the lung can beevacuated by negative pressure communicated through the suction cathetertube 34 when the control valve 40 is activated without injury to thepatient. It should, therefore, be appreciated that the insertion guide44 provides for facile and accurate placement of the catheter tube 34 inthe respiratory system of a patient and is particularly helpful to avoidlung damage when the patient is an infant or child.

Preferably, the control valve 40 is preferably identical orsubstantially identical to the control valve described in U.S. Pat. No.4,569,344, as is the male coupling member 46, the connection site 44,the collar 42. No further description is believed to be necessary inregard to the control valve 40 and the indicated adjacent structure, thedisclosure of U.S. Pat. No. 4,569,344 being incorporated herein byreference.

Reference is now made to FIGS. 6-8, which illustrates a furtherembodiment of the present invention, i.e. an insertion control device,generally designated 180, for restricting to a predetermined length theamount of the suction catheter tube 34 which is available to be insertedinto the respiratory system of a patient. This prevents occlusion due tokinking, and lung damage by reason of excessive insertion, which wouldotherwise risk puncturing the lung of an infant.

The insertion control mechanism 180 comprises a sleeve 182 and a collar184. The sleeve 182 is illustrated as having a radial flange 184 at oneend interposed between a blunt forward edge 186 and a shoulder 188. Theflange 184 is centrally hollow, the hollow forming part of an internalaxial bore 190 of uniform dimension throughout, the unstressed diameterof which is only slightly greater than the exterior diameter of thecatheter tube 34. Thus, the sleeve 182 can be axially displaced relativeto the catheter tube 34 when the sleeve 182 is unstressed andsuperimposed telescopically upon the catheter tube 34.

The flange 184 merges with a rearwardly directed ring segment 192. Ringsegment terminates at blunt traverse edge 197. The bore 190 expandsthrough the ring 192 so that is spans the full length of the sleeve 182.The ring 182 has a rearwardly convergent circular exterior surface 194,for purposes hereinafter more fully described. A pair of aligned slots196 span from the blunt end surface 186 rearwardly across the entiretyof the flange 184 and a substantial distance along each side of the ring192, for purposes hereinafter more fully explained.

The collar 184 is illustrated as being of relatively short length andcomprises an exterior annular surface 198 and blunt forward and rearwardedges 200 and 202. The diameter of the exterior surface 198 isillustrated as being slightly greater than the diameter of the flange184. See FIG. 6, which comprises a side elevation view of the assembledinsertion control device 180. The collar 184 comprises an axialthroughbore 204 which tapers divergently from left to right, as viewedin FIG. 7.

The bore 204 is sized and shaped so that the diameter thereof adjacentsurface 200 is slightly greater than the diameter of the ring 192 at thetrailing end 197 so that the collar 184 can be readily advancedtelescopically upon the ring 192. The bore 204 is sized and shaped sothat the diameter thereof adjacent trailing edge 202 of collar 184 issomewhat less than the unstressed diameter of the ring 192 directlyadjacent the shoulder 188. Consequently, when the collar 184 is fullyadvanced telescopically upon the ring 192 into the assembled positionillustrated in FIG. 6, the collar 184 compresses the ring 192 and thecollar 184 adjacent the shoulder 188 thereby closing or tending to closethe two opposed slots 196. This causes the ring 192 and the collar 184to pinch or compressively engage the exterior surface of the suctioncatheter tube 34 to the extent that relative axial movement of theinsertion control device 180 along the catheter tube 34 cannot occurthereafter.

To install the insertion control 180, the separated sleeve 182 andcollar 184 are advanced sequentially along the exterior surface of thesuction catheter tube 34 until the sleeve 182 is at a desired locationalong the catheter tube. This location can be ascertained by measurementor by placing length indicia on the exterior of the suction cathetertube, as illustrated in FIGS. 2 and 6. When the sleeve 182 has beenplaced in superposition upon the suction catheter tube 34 and displacedto the desired location, the collar 184 is force-fit upon the ring 192forcing the insertion control device 180 into the assembled lockedposition illustrated in FIG. 6. The insertion control device 180 isillustrated as being located about 22 centimeters to the rear of the tip120 of the suction catheter tube 34.

As a consequence, when the catheter tube 34 is advanced into therespiratory system of a patient, the forward edge 186 will ultimatelycome in contact with some other stationary part of the apparatus 30,such as the fitting 32. In the alternative, if the insertion guide 44 isalso used, the ring 168 thereof will form a stationary stop againstwhich the forward edge 168 of the control device 180 will abut toprevent further insertion of the suction catheter tube 34. See FIG. 8.

It is to be appreciated that the insertion control device 180 may besubsequently telescopically separated into its components and relocatedto a different position should medical personnel choose to use a longeror shorter length of suction catheter tube in the respiratory system ofa patient.

Reference is now made to FIGS. 11 through 14 which illustrate a furtherembodiment of the present invention, more particularly an adaptor forinterpositioning between an exposed fitting 218 of indwellingendotracheal tube and an aspirating apparatus or ventilating/aspiratingapparatus. It is to be appreciated that the adaptor in question,generally designated 210, can interconnect an endotracheal tube with,for example, a single-use aspirating device, or a multiple useaspirating/ventilating device. Such connection is diagrammaticallyillustrated at female fitting 212 in FIG. 11.

The structure and placement of the endotracheal tube 214, illustrated inFIG. 11, is conventional. The endotracheal tube 214 is conventional andcomprises an exposed proximal end 218.

The adaptor 210 is best shown in FIGS. 12-14, in reverse orientation.The adaptor 210 comprises a central exposed radial flange 220 whichdefines opposed shoulders 222 and 224. The flange 220 merges integrallywith a rearward extension 226, which defines a cylindrical exteriorexposed surface 228 to receive an aspirating or aspirating/ventilatingapparatus at an appropriate fitting thereof in snug force-fit air-tightrelation. The extension 226 comprises a trailing blunt edge 229, whichmerges into a conically-shaped counterbore 230 , which in turn emergeswith a central axially-directed bore 232. The purpose of the taperedcounterbore 230 is to deflect the leading end of a suction catheter tubeassociated with the aspirating or aspirating/ventilating apparatusconnected to the adaptor 210 so as to direct the tip into and throughthe central bore 232 when the tube 34 is being placed in the respiratorysystem. The bore 232 is sized and shaped so as to receive the suctioncatheter tube when the same is co-axially advanced therethrough and toaccommodate a force-fit union between the surface 236 and the interiorof the exposed end of the endotracheal tube.

The adaptor 210 further comprises a forwardly directed male tip 234through which the bore 232 also axially passes. The exterior surface 236of the male tip 234 is forwardly divergently tapered and otherwise sizedand shaped to be snugly received in air-tight relation within theexposed end 218 of the endotracheal tube 214, whereby the suctioncatheter tube passing through the bore 232 of the fitting 210 will becaused to be directed into the hollow interior of the endotracheal tube214 and thence into the respiratory system of the patient 238.

The extension 226 comprises cavities 240 to eliminate use of unnecessarysynthetic resinous material when the adaptor 210 is preferably formed asone piece using injection molding techniques. For strength, however,radial flanges 242 exist between the cavities 240.

The axial bore 232 is interrupted and intersected openly by transversebore 244 (FIG. 13). The bore 244 is formed in the flange 220 andincludes a stepped counter-bore portion 246 slightly greater in interiordiameter than the bore 244 but essentially equal to the outside diameterof a hollow plastic tube 248 which is placed in the counterbore 246 andadhesively or bondedly retained therein. The tube 248 is connected atsite 250 with a female sleeve fitting 252. The female fitting 252 isnormally closed by a press-fit cap 254 integral therewith by reason of atether 256.

With the endotracheal tube 214 indwelling, the adaptor 210 press-fitinto the exposed end 218 of the endotracheal tube, the aspiratingapparatus comprising fitting 212 secured to the adaptor 210 and thesuction catheter tube of the aspirating apparatus withdrawn, medicalpersonnel can selectively remove the cap 254 and selectively inject alavage solution of proper makeup and dilution through the female fitting254, the hollow interior of the tube 248, the bore 232 and thence downthe endotracheal tube 214 into the lungs of the patient for purposes ofloosening accumulated secretions in the lungs. This accommodatessubsequent removal of the loosened secretions via the mentioned suctioncatheter tube when appropriately inserted into the lungs of the patient.

The flange 220 is illustrated as comprising opposed outwardly directedtabs 258, sized and shaped so that the adaptor 210 may be easilymanually manipulated.

Specific reference is now made to FIGS. 15-19, which illustrates afurther embodiment of the present invention, i.e. an observation chambergenerally designated 270 interposed in the suction catheter tube flowpath between the trailing end of the envelope 36 of apparatus 30' andthe suction control valve 40.

As stated earlier, the suction control valve 40 is known in the art andis disclosed in the U.S. Pat. No. 4,569,344. Control valve 40, as bestillustrated in FIG. 16, comprises a female recess 272 sized and shapedfor appropriate fluid communication connection to the secretionobservation chamber 270. The apparatus 30' comprises the heretoforedescribed, collapsible envelope 36, suction catheter 34 and connector44, integrally joined to the trailing end of the catheter tube 34. Thefitting 44 integrally joins a fitting, generally designated 274. Thefitting 274 comprises a forwardly projecting extension 276 whichcomprises the cylindrical exterior of predetermined diameter interruptedby an annular radially extending rib 278. The envelope 36, at thetrailing end thereof, is collapsed into contiguous relation with thecylindrical surface 276, with a collar 280 disposed in surroundingrelation to the envelope 36 but forwardly offset from the surface 276.

The collar 280 is annular in its configuration defining a cylindricalexterior surface 282 having a diameter slightly larger than the diameterof the cylindrical surface 276 of the fitting 274. The internal surface284 of the collar 280 is interrupted by spaced ribs 286. The diameter ofthe surface 284 and the annular ribs 286, which project radiallyinwardly, are sized and shaped so that forced advancement of the collar280 over the trailing end of the envelope 36 into superposition with thecylindrical surface 276 creates a force-fit connection between thefitting 274 and the trailing end of the envelope 36 between ribs 286 and278. The cylindrical surface 276 of the fitting 274 comprises part of anannular wall 290 (FIG. 17) which also defines an annular interior wallsurface 292.

Concentric with the wall 290 is a wall 294, illustrated as havinguniform thickness defining an exterior cylindrical surface 296 and aninterior cylindrical surface 298. The fitting 44 integrally carried atthe trailing end of the suction catheter tube 34 is sized and shaped tosnugly fit within wall 294 at surface 298 where it is adhesively orotherwise stationarily secured against inadvertent separation. Thus, thehollow bore at 300 is placed in direct fluid communication with thehollow interior of the suction catheter tube 34.

The fitting is illustrated as comprising a construction at orifice at302, which comprises a forward shoulder 304 and a larger rearwardlydirected shoulder 306. Thus, the central bore is enlarged at bore 308which is disposed at the trailing end of the fitting 274.

The exterior cylindrical surface 276 merges at shoulder 310 with anexterior cylindrical surface 312 of larger diameter. The cylindricalsurface 312 comprises wall 314 which is of uniform thickness and definesalso an internal cylindrical or annular surface 316. Shoulder 306 mergeswith an annular projection 318, which comprises an exterior cylindricalsurface 320 and an interior cylindrical surface 322. Cylindrical surface322 defines the enlarged bore section 308. The diameter of the exteriorsurface 320 is substantially smaller than the diameter of thecylindrical surface 316 thereby defining an annular recess 324therebetween. Radial strengthening ribs 326 span between the walls 314and 318 to provide strength and stability, as best shown in FIG. 19.

The observation chamber 270 is tubular and has a funnel shape. Thus, theobservation chamber 270 is both interiorly and exteriorly tapered.Observation chamber 270 comprises a length of transparent tubing of thementioned tapered configuration 332. The tubing 332 is centrally hollow,defining a central bore 334, which has a diverging configuration fromleft to right. The wall 332 is of substantially uniform thicknessthroughout, with the exception that a cylindrical seat 336 is defined atthe larger leading end at the interior thereof. The cylindrical seat 336extends from the blunt leading edge 338 of the tubing 332 to an interiorannular shoulder 340. The diameter of the annular seat 336 issubstantially the same as the diameter of the cylindrical surface 320 ofthe fitting 274. Thus, by placing a suitable bonding agent or adhesivebetween the rearward portion of surface 320 and/or the surface definingthe seat 336, joining of the fitting, at projection 318 with the taperedtubing 332 is made permanent and inseparable.

The observation chamber 270 comprising tube 332 is transparent,preferably formed of acrylic of medical grade. The taper of the bore 334provides for initial introduction of the secretions withdrawn from thelungs of a patient through the suction catheter tube 34 to flow slowlyinto the observation chamber 270 and more rapidly thereafter foraccurate visual observation of the rate of flow of the secretions, theapproximate quantity of the flow, as well as the color, texture andother characteristics of the secretions. The wall 332, at the trailingend, defines a cylindrical surface 342, which terminates in a blunttransverse edge 344. The diameter of the surface 342 is selected to besubstantially the same as the diameter of the recess 272 in the suctioncontrol valve 40 so that a bonding agent may be interposed between thetwo and the two interposed in contiguous relation to create a permanentunion therebetween.

The invention may be embodied in other specific forms without departmentfrom the spirit or essential characteristics thereof. The presentembodiments, are, therefore, to be considered in all respects asillustrative and not restrictive, the scope of the invention beingindicated by the appended claims rather than by the foregoingdescription, and all changes which come within the meaning and range ofequivalence of the claims are therefore to be embraced therein.

What is claimed and desired to be secured by U.S. Letters Patent is: 1.An aspirating apparatus for respiratory therapy on a medical patientcomprising:distal end fitting means by which the apparatus is connectedto an exposed proximal end of an indwelling endotracheal tube; a suctioncatheter tube having a hollow interior for selective advancement throughthe fitting means and the endotracheal tube into the respiratory systemof the patient for removal of lung secretions; fluid flow communicatingmeans by which the hollow interior of the suction catheter tube isplaced in fluid communication with negative pressure for suction removalof said lung secretions along a flow path comprising the hollow interiorof the suction catheter tube; observation chamber means disposedproximally of the proximal end of the suction catheter tube and forminga part of the secretion flow path, the observation chamber means free ofany and all visual obstructions by any other part of the apparatus forvisual observations of the flow and composition of secretions beingremoved from the patient under force of said negative pressure whereinthe observation chamber means are disposed proximal of the proximal endof the suction catheter tube and has a hollow interior in fluidcommunication with the hollow interior of the suction catheter tube, theinterior transverse dimensions of which are substantially and materiallylarger than the transverse dimensions of the hollow interior of thesuction catheter tube whereby the rate of flow of secretions issubstantially lowered upon entry into the observation chamber means thanin the suction catheter tube to permit visual inspection of not only theflow and quantity of secretions so removed from the patient but also thecolor, texture, viscosity and other visually-observable characteristicsof the secretions.
 2. An aspirating apparatus for respiratory therapy ona medical patient comprising:distal end fitting means by which theapparatus is connected to an exposed proximal end of an indwellingendotracheal tube; a suction catheter tube having a hollow interior forselective advancement through the fitting means and the endotrachealtube into the respiratory system of the patient for removal of lungsecretions; fluid flow communicating means by which the hollow interiorof the suction catheter tube is placed in fluid communication withnegative pressure for suction removal of said lung secretions along aflow path comprising the hollow interior of the suction catheter tube;observation chamber means disposed proximal of the proximal end of thesuction catheter tube and has a tapered hollow interior in fluidcommunication with the hollow interior of the suction catheter tube, theinterior transverse dimensions of which are substantially and materiallylarger than the transverse dimensions of the hollow interior of thesuction catheter tube with the interior of the observation chamber meansat the distal end being diametrally greater then the interior of thesuction catheter tube at the proximal end of the observation chambermeans, said observation chamber means being substantially uniformlyinteriorly convergently tapered between the distal end and the proximalend of the observation means whereby the rate of flow of secretions issubstantially lowered upon entry into the observation chamber means thanin the suction catheter tube to permit visual inspection of not only theflow and quantity of secretions so removed from the patient but also thecolor, texture, viscosity and other visually-observable characteristicsof the secretions.